Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

There are no reliable genetic toxicity studies available for the UVCB substance itself. A full and detailed justification for a category approach for meeting the individual data requirements for glycol ethers is included as an attachment in chapter 13 to the dossier submitted by the lead registrant.  From this analysis there is clear evidence across the whole category that the E series glycol ethers do not show genotoxic properties. Extrapolation of experimental data from a closely related member of the glycol ether family (in this case the methyl glycol ether member(s) of the triethylene glycol alkyl series (2-(2-(2-methoxyethoxy)ethoxy ethanol – TEGME) is scientifically justified. There is a full battery of studies available for a the latter, the summaries of which are described below:

In a guideline (TSCA) and GLP bacterial reverse mutation assay (Salmonella strains TA98, TA100, TA1535, TA1537) triethylene glycol methyl ether TEGME or 2 -(2 -(2 -methoxyethoxy)ethoxy)ethanol tested at concentrations up to 5000 ug/plate did not produce evidence of mutation with or without exogenous metabolic activation by rat liver S-9. In a GLP and guideline (TSCA) CHO / HGPRT mammalian gene mutation assay, TGME tested at concentrations up to 5000 ug/ml did not produce evidence of mutation with or without exogenous metabolic activation by rat liver S-9.

Brake Fluid DOT 4, a mixture primarily of borated and unborated triethylene glycol methyl ether, was tested for potential to cause chromosomal aberrations (CA) in cultured Chinese hamster ovary cells (CHO), at concentrations up to 5000 micrograms/mL, in the presence or absence of S9 mix. No treatment-related increase in incidence of chromosomal aberrations was observed with the test substance. Positive controls benzo(a)pyrene, and methylmethanesulfonate showed significantly increased CA formation.

In a GLP and guideline (TSCA) CHO / HGPRT gene mutation assay, TEGME tested at concentrations up to 5000 ug/ml did not produce evidence of mutation with or without exogenous metabolic activation by rat liver S-9.

It is reasonable to extrapolate these results to predict that none of the components of this UVCB substance would have any significant genotoxic potential.


Short description of key information:
Ames studies: negative study in surrogate substance
Cytogenicity study: negative study in surrogate substance
In vitro mammalian cell gene mutation study: negative study in surrogate substance

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There is no indication of genotoxic potential. Classification is not required.

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